Страна: Великобритания
Език: английски
Източник: VMD (Veterinary Medicines Directorate)
Closantel
Krka d.d., Novo Mesto
QP52AG09
Closantel
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Sheep
Anthelmintic
Expired
2018-03-06
Revised: August 2019 AN: 00461/2019 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Santiola 50 mg/ml solution for injection for cattle and sheep (BG, CZ, EE, GB, HR, HU, IE, LT, LV, RO, SI, SK) Santiola vet 50 mg/ml solution for injection for cattle and sheep (DK, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains ACTIVE SUBSTANCE: Closantel 50 mg (equivalent to closantel sodium dihydrate 54.375 mg ) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear light yellow to yellow or brown yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of the following trematodes (fluke), gastro-intestinal nematodes and arthropods if sensitive to closantel. _SHEEP_ TREMATODES _Fasciola hepatica_ (adult) _Fasciola gigantica _(adult and 8 weeks immature) NEMATODES _Haemonchus contortus _(adult and immature)_ _ _Oesophagostomum columbianum_ (adult and immature) _Gaigeria pachyscelis_ (adult and immature) _Chabertia ovina_ (adult and immature) ARTHROPODS _Oestrus ovis _(1 st , 2 nd and 3 rd instar) Revised: August 2019 AN: 00461/2019 Page 2 of 7 _CATTLE_ TREMATODES _Fasciola hepatica_ (adult) _Fasciola gigantica_ (adult and 8 week immature) NEMATODES _Haemonchus placei_ (adult and immature) _Bunostomum phlebotomum _(adult and immature) _Oesophagostomum radiatum_ (adult and immature) ARTHROPODS _Hypoderma bovis_ (dermal stages) _Hypoderma lineatum _(dermal stages) 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the stated dose. Care should be taken to ensure that all injection procedures are correctly carried out and body weights accurately assessed. Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective t Прочетете целия документ